Why a Drug to Prevent HIV Infection Is in Low Demand
The Wall Street Journal
December 21, 2015
by Sumathi Reddy

Public-health officials push wider use of PrEP, but some AIDS organizations lobby against the medication -

Public-health officials are pushing for much wider use of a drug that has proved effective at preventing HIV infection.

PrEP, or preexposure prophylaxis, is a daily medication that people at high risk for HIV can take to protect against acquiring the virus, which causes AIDS. The drug Truvada was approved by the Food and Drug Administration in 2012 for use as PrEP. About 50,000 people a year in the U.S. become infected with HIV, according to the Centers for Disease Control and Prevention.

Still, fewer than 22,000 people are estimated to have taken PrEP for prevention, according to an analysis this year in the journal Current Opinion in HIV and AIDS. AIDS remains a significant cause of death in certain populations although treatments have made living with the syndrome a reality for many.

The CDC in November released a report suggesting some 1.2 million U.S. adults who are at substantial risk for acquiring HIV could benefit from PrEP. Among those are one in four gay and bisexual men; one in five people who inject drugs; and one in 200 sexually active heterosexuals.

Taking PrEP reduces the risk of HIV infection through sexual transmission by as much as 92% and by about 70% in people who inject drugs, the CDC says. Still, one in three primary care doctors haven’t heard of the medication, according to a 2015 CDC survey.

The agency has issued clinical guidelines with charts and checklists to assist health-care providers during patient evaluations, and offers a telephone hotline for people to get free expert clinical advice on PrEP. “As with any new health intervention, it will take time for people to learn about and become comfortable with PrEP,” a CDC spokeswoman said.

“More high-risk individuals need to know about the benefits of PrEP and more physicians need to know about it,” said Carlos del Rio, chairman of the Infectious Disease Society of America’s HIV Medicine Association and a professor at Emory University. “We can really decrease the number of new HIV infections if PrEP is used more.”

PrEP can cost between $8,000 and $14,000 a year, although it is covered by most private insurers and by Medicaid in many states. Assistance programs, including one from Gilead Sciences, the maker of Truvada, are available for those without insurance. The drug, which is also used in HIV treatment, has mostly minimal side effects, doctors say.

Some AIDS organizations don’t promote use of the drug, partly out of concern it could encourage more risky sexual behavior. “We are having an explosion of other sexually transmitted diseases impacting the gay community and PrEP offers no protection whatsoever for any other disease,” said Ged Kenslea, communications director for AIDS Healthcare Foundation, a Los Angeles-based global AIDS organization.

Mr. Kenslea said the group disagrees with the CDC’s goal of getting 1.2 million people on PrEP. “The patient must take the [PrEP] pill; we can’t even get people who are already HIV positive to take their pills every day,” he said. The foundation last week began a national ad campaign, entitled “PrEP: The Revolution That Didn’t Happen,” in gay and lesbian publications in major cities. It aims in part to encourage the CDC to focus on other prevention methods, such as condoms, and to devote its resources to HIV treatment.

Research has shown PrEP’s effectiveness. A continuing randomized controlled trial in England, which has been following more than 500 men at risk for contracting HIV, found that participants taking PrEP were 86% less likely to get infected than those not on the drug. The study, published in the journal the Lancet in September, also found that the people on PrEP reported more unprotected sex, but there was no evidence of an increase in sexually transmitted diseases.

Researchers at Kaiser Permanente in California followed 657 noninfected people taking PrEP for an average of seven months and found none of the participants contracted HIV, said Jonathan Volk, lead author of the study and a physician with Kaiser Permanente San Francisco Medical Center. “That’s really compelling data on how effective this medication is,” he said.

After one year on PrEP, however, about half of the users were diagnosed with at least one sexually transmitted disease. And nearly half the participants in a representative subset said they used condoms less frequently after starting PrEP, Dr. Volk said. The study was published in September in the journal Clinical Infectious Diseases.

Albert Liu, a clinical research director at the San Francisco Department of Public Health, said a study he led shows that most people will take PrEP as prescribed if they have access to the medication. San Francisco has made efforts to expand the availability of PrEP over the past year, including offering it in a number of clinics.

The study, published in November in JAMA Internal Medicine, followed 557 gay men and transgender women who were provided PrEP for a year in clinics in San Francisco and Miami and a community health center in Washington, D.C. More than 80% of the participants had protective levels of PrEP in their bloodstream, suggesting a high level of adherence to the medication regimen, Dr. Liu said.

The study also found that among the participants, “risky behavior either declined or remained the same,” Dr. Liu said.

“My belief is that PrEP doesn’t change people’s behavior,” said Paul Marcelin, a 41-year-old software engineer in Alameda, Calif., who has been taking the drug since July 2013.

Mr. Marcelin said more people in the gay community have begun advertising if they are on PrEP in online- and social-media-dating profiles. “Now, [PrEP] is much more commonplace, at least in San Francisco,” he said.